Investigate the Maximum Tolerated Dose of Vandetanib and Concurrent Whole Brain Radiotherapy (WBRT) in Patients With Non-small Cell Lung Cancer (NSCLC) and Brain Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-08-31

Brief Summary

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A clinical study to investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases. All patients will receive WBRT, 10 fractions of 3 Gy. Patients will start 7 days prior to start of radiation treatment with Vandetanib. Total treatment time with Vandetanib is 3 weeks (21 days). Patients will have the opportunity to continue Vandetanib until progression at a dose of 300 mg. This multi-centre study will be conducted in a minimum of 9 patients and a maximum of 18 patients at 3 sites.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZACTIMA TM

Group Type EXPERIMENTAL

ZD6474 (Vandetanib)

Intervention Type DRUG

100 mg as a once daily oral dose, 21 days

Whole Brain Radiotherapy (WBRT)

Intervention Type RADIATION

ZD6474

Intervention Type DRUG

200 mg as a once daily oral dose, 21 days

ZD6474

Intervention Type DRUG

300 mg as a once daily oral dose, 21 days

Interventions

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ZD6474 (Vandetanib)

100 mg as a once daily oral dose, 21 days

Intervention Type DRUG

Whole Brain Radiotherapy (WBRT)

Intervention Type RADIATION

ZD6474

200 mg as a once daily oral dose, 21 days

Intervention Type DRUG

ZD6474

300 mg as a once daily oral dose, 21 days

Intervention Type DRUG

Other Intervention Names

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ZACTIMA TM ZACTIMA TM ZACTIMA TM

Eligibility Criteria

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Inclusion Criteria

* Male and female patients aged above 18 years with histologically or cytologically confirmed NSCLC and contrast-enhanced CT scan or Gadolinium-enhanced MRI confirmed brain metastases who have a performance status of 0 to 2
* No previous radiotherapy, surgery or chemotherapy for brain metastases
* Patients should not have any unstable systemic disease

Exclusion Criteria

* Serious abnormal laboratory values
* Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
* Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease \>2 within 3 months before entry; or presence of cardiac disease that, in the
* Previous randomization of treatment in the present study and/ or current participation in another clinical study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No